Phase 2 Liver Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have agreed to take part and have signed a consent form
• People aged 18 to 75 years old (male or female)
• People who have been clinically or pathologically diagnosed with hepatocellular carcinoma (a type of liver cancer) and have at least one measurable area of cancer that has not had local treatment, meeting specific size requirements on a spiral CT scan
• People with a Child-Pugh score (a measure of liver disease severity) of 13 points or below (confirm with trial site)
• People with BCLC-C stage liver cancer (an advanced stage) along with high blood pressure in the portal vein caused by a blood clot from the tumour (confirm with trial site)
• People who are newly diagnosed and have not previously received targeted therapy or immunotherapy
• People with an ECOG performance score of 0 or 1 (meaning they are fully active or have only mild restrictions on physical activity)
• People whose doctors estimate they have a life expectancy of at least 12 weeks
• People whose blood and organ function test results meet specific minimum levels, including adequate counts of white blood cells, platelets, and haemoglobin, as well as acceptable levels of liver, kidney, and thyroid function
• Women of childbearing age who have agreed to use an approved contraceptive method during the study and for 3 months after it ends, and who have a negative pregnancy test within 72 hours before joining, and who are not breastfeeding
• Male participants whose partners are women of childbearing age who have agreed to use effective contraception during the study and for 3 months after it ends

Who may not be able to join:

• People who have or have had an active autoimmune disease (a condition where the immune system attacks the body)
• People who are currently taking immunosuppressive medications or high-dose steroid medicines (above a certain threshold) within 2 weeks before joining
• People who have already received two or more lines of systemic (whole-body) treatment for this cancer
• People who have had a severe allergic reaction to other monoclonal antibody medicines
• People with a known history of cancer spreading to the brain or spinal cord (central nervous system metastasis), or a history of hepatic encephalopathy (brain problems caused by liver disease)
• People who have previously had a liver transplant
• People whose tumour blood clot has spread beyond the portal vein into other blood vessels such as the hepatic vein, inferior vena cava, right atrium, splenic vein, or superior mesenteric vein
• People with high blood pressure that cannot be adequately controlled with blood pressure medication (systolic at or above 140 mmHg or diastolic at or above 90 mmHg)
• People with serious heart conditions that are not well controlled, including moderate-to-severe heart failure, unstable chest pain, a heart attack within the past year, certain serious heart rhythm problems, or an abnormal heart electrical reading above a specified level
• People with abnormal blood clotting test results, a tendency to bleed, or who are currently receiving clot-dissolving or blood-thinning therapy (note: low-dose aspirin and low molecular weight heparin for prevention are permitted)
• People with a Child-Pugh score above 13 points
• People who have experienced a serious blood clot or stroke event in the 6 months before joining, including stroke, mini-stroke, brain bleed, deep vein thrombosis, or pulmonary embolism
• People with a known inherited or acquired tendency to bleed or form clots (such as haemophilia), or who have high levels of protein in their urine above a specified threshold
• People who have recently completed other cancer treatments (such as radiotherapy, chemotherapy, hormone therapy, or surgery) within 4 weeks before the study, or targeted therapy within 5 drug half-lives, or whose side effects from previous treatments have not sufficiently resolved
• People who have an active infection, an unexplained fever of 38.5°C or above within 7 days before starting the study, a very high white blood cell count, or a known immune deficiency condition such as HIV
• People with moderate to severe pulmonary hypertension (high blood pressure in the lungs), with pulmonary artery pressure above 40 mmHg on ultrasound
• People who have been diagnosed with another cancer in the past 3 years or currently, except for certain fully treated skin cancers or cervical carcinoma in situ
• People who have previously received anti-PD-1 or anti-PD-L1 immunotherapy, or have previously been treated with apatinib
• People who have received a live vaccine within 4 weeks before starting the study, or who may need a live vaccine during the study
• People who, in the opinion of the investigating doctor, have other circumstances that could affect study results or safety, such as serious ongoing illness, significant mental health conditions, alcohol or drug misuse, or significant social or family factors

Important: Always verify eligibility with the trial site directly before applying.